Properties of different pancreatin preparations used in pancreatic exocrine insufficiency

Piehl, Susanne; Brinkmann, Robert; Windeck, Timo

doi:10.1097/meg.0b013e328334de34

Cited by 1 publication

(3 citation statements)

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“…In response to the study by Löhr and colleagues, it was argued that in patients with PEI, lipase release at pH 5 could be advantageous due to possibly impaired bicarbonate secretion in these patients [20]. In principle, this statement was supported by Löhr in his response to this argument.…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, in a previous study comparing PERT preparations, a particle size of less than 1.7 mm was proposed to be beneficial [12]. The relevance of the particle size was discussed in two letters to the editor in response to the study by Löhr and colleagues [19,20]. However, since several studies have demonstrated a pivotal role of a particle size of 2 mm or less, at this point it seems reasonable to regard a small particle size as beneficial [12].…”

Section: Discussionmentioning

confidence: 99%

“…In principle, this statement was supported by Löhr in his response to this argument. However, since pancreatic lipase activity is only 10-20% between pH 5 and pH 6, it was concluded that the properties of this enzyme do not allow major lipase activity below pH 6 [20,26]. More recently, lipases from the ciliate Tetrahymena thermophila have been characterized, which are highly active within a pH range from pH 2.0 to pH 9.0, highly active in the presence of bile salts, and more stable after incubation in human gastric juice compared to porcine lipase or rizolipase.…”

Section: Discussionmentioning

confidence: 99%

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Comparative Investigation of pH–Dependent Availability of Pancreatic Enzyme Preparations In Vitro

Todd,

Bennett-Huntley,

Rosendahl

et al. 2024

Pharmaceuticals

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This study aimed to compare different pancreatic enzyme preparations (PEPs) available in Germany regarding particle geometry and size, and to evaluate enzyme activity under physiologically relevant conditions in vitro. Pancreatic endocrine insufficiency is characterized by deficiency of pancreatic enzymes resulting in maldigestion. It is orally treated by pancreatic enzyme replacement therapy. The formulations differ in their physical properties and enzyme release behavior, potentially resulting in inconsistent dosages and poor interchangeability of products. A total of 25 products were analyzed for particle size and number of particles per capsule. Enzyme activities of lipase, amylase, and protease were measured by digestion of olive oil emulsion, starch, and casein, respectively. To analyze enzyme release, gastric environments were simulated by incubating PEPs at pH 1, 4, or 5. Duodenal conditions were simulated by subsequent incubation at pH 6. Regarding physical properties and enzyme release kinetics, considerable differences between different PEPs were found. Furthermore, compared to the label claim, excess lipase activity was observed for most products, reaching up to 148%. These in vitro results suggest poor interchangeability of PEPs, potentially explained by physical and release characteristics. Physicians and patients should be aware of the potential gap between label claims and the real-life performance of different PEPs.

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Section: Discussionmentioning

confidence: 99%